NCT05828030

Brief Summary

Guidelines for noninvasive ventilation (NIV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic . However, no any suggestion was applied for high flow nasal cannula (HFNC). Therefore, Our aim was to determine whether HFNC reduces intubation in severe trauma-related hypoxemia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Dec 2027

First Submitted

Initial submission to the registry

April 3, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 26, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

3.7 years

First QC Date

April 3, 2023

Last Update Submit

September 1, 2025

Conditions

Chest TraumaHypoxia

Outcome Measures

Primary Outcomes (1)

  • Rate of event of intubation or pneumonia

    Intubation criteria included a respiratory rate of \>40 breaths per minute, signs of increased breathing effort, SpO2 of \<90% despite high fraction of inspired oxygen inspired oxygen fraction or acidosis with the quantitative measure of the acidity or basicity of aqueous or other liquid solutions (pH scale) of \<7.35, occurrence of hemodynamic instability or deterioration of neurologic status.

    30 days after randomization

Secondary Outcomes (2)

  • P/F ratio

    48 hrs after randomization

  • pneumonia rate /tracheostomy rate

    30 days after randomization

Study Arms (2)

high flow nasal cannula group

EXPERIMENTAL

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at titrated from 60 L/min.

Procedure: high flow nasal cannula

Oxygen Mask group

ACTIVE COMPARATOR

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

Procedure: Oxygen mask

Interventions

high flow nasal cannulaPROCEDURE

the patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

high flow nasal cannula group
Oxygen maskPROCEDURE

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

Oxygen Mask group

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe hypoxemic respiratory failure \[Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen fraction(FiO2) \<300 mmHg\]
  • with a respiratory rate \>25 breaths/minute and difficulty breathing, or respiratory distress

You may not qualify if:

  • Patients with a Glasgow Coma Scale less than 8 or severe brain injury.
  • Patients with any contraindications to non-invasive ventilation, including acute gastrointestinal bleeding, upper airway obstruction, or hemodynamic instability.
  • Facial trauma involving skull base fractures, facial bone fractures, or orbital floor fractures.
  • Severe injuries involving the nasal sinuses.
  • Patients with cervical spine injuries.
  • Patients with increased intracranial pressure.
  • Patients with facial, nasal, or airway structural abnormalities or surgery that prevents the use of appropriate nasal cannula.
  • Patients after upper airway surgery.
  • Patients who are unable to clearly express their willingness to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Traumatology, National Taiwain University Hospital

Taipei, Taipei, 10002, Taiwan

RECRUITING

NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch

Taipei, Taiwan, 100; 300; 640; 280, Taiwan

RECRUITING

MeSH Terms

Conditions

Thoracic InjuriesHypoxia

Condition Hierarchy (Ancestors)

Wounds and InjuriesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hsien-Chi Liao, MD

    department of trauma of National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsien-Chi Liao, MD

CONTACT

+886-972651611polarisliao@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 25, 2023

Study Start

April 26, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)